Sickle Cell Anemia Testing and Screening Market Shaped by Early Diagnosis Demand

Revenue, 2025

USD 482.2 Million

Forecast, 2035

USD 1516.47 Million

CAGR, 2026-2035

12.14%

Report Coverage

Global

Sickle Cell Anemia Testing and Screening Market Size, Insights and Key Players with Trends

The global sickle cell anemia testing and screening market size was estimated at USD 482.2 million in 2025 and is predicted to increase from USD 540.74 million in 2026 to approximately USD 1516.47 million by 2035, expanding at a CAGR of 12.14% from 2026 to 2035.

The sickle cell anemia testing and screening market is expanding rapidly worldwide due to rising disease prevalence, newborn screening initiatives, and technological advances like genetic and point-of-care diagnostics. Demand is growing in both developed and emerging regions, with efforts to improve early detection and access to accurate, rapid testing driving broader adoption and infrastructure investment.

Key Takeaways

• Sickle cell anemia testing and screening sector pushed the market to USD 540.74 million by 2026.
• Long-term projections show USD 1516.47 million valuation by 2035.
• Growth is expected at a steady CAGR of 12.14% in between 2026 to 2035.
• North America dominated the sickle cell anemia testing and screening market in 2025.
• Asia Pacific is expected to grow at the fastest CAGR in the market during the forecast period.
• By technology, the hemoglobin electrophoresis segment held the largest market share in 2025.
• By technology, the point-of-care tests segment is expected to grow at the fastest CAGR in the market during the forecast period.
• By age group, the newborn screening (12 months and below) segment led the market.
• By age group, the other age groups (1 to 25 & above 60 years) segment is expected to grow at the fastest CAGR in the market during the forecast period.
• By sector type, the government labs segment dominated the market.
• By sector type, the private labs segment is expected to grow at the fastest CAGR in the market during the forecast period.

Key Indicators and Highlights

Early Detection Driving Hope: Rising Demand for Sickle Cell Anemia Testing and Screening

• Sickle and anemia testing and screening refer to laboratory and genetic tests used to identify sickle cell disease or carrier status, enabling early diagnosis, timely treatment, and informed clinical or reproductive decision-making.
• The sickle cell anemia testing and screening market is growing due to rising disease prevalence, increased newborn screening programs, and greater awareness of early diagnosis benefits. Advances in genetic and point-of-care testing, supportive government initiatives, and expanding healthcare access in emerging regions are also driving demand for timely, accurate screening and preventive care.

How AI Can Affect the Market?

The sickle cell anemia testing and screening market is growing largely independent of AI due to mandatory newborn screening programs, rising disease prevalence, and strong government-led public health initiatives. Growth is driven by established diagnostic methods, expanding healthcare infrastructure, and increased awareness of early detection benefits, rather than reliance on advanced AI-based technologies in routine screening workflows.

Trend and Future Outlook of the Sickle Cell Anemia Testing and Screening Market

Expansion of Newborn & Population Screening Programs

Governments and health agencies are broadening mandatory screening initiatives worldwide, increasing early diagnosis rates and reducing complications. This trend will enhance public health outcomes and drive sustained demand for reliable testing solutions.

Technological Advancements in Diagnostics

Innovations like rapid assays and more sensitive genetic tests are improving accuracy and turnaround times. Future adoption of these technologies will streamline screening processes and widen accessibility.

Growth in Emerging Markets

Improved healthcare infrastructure and awareness in Africa, Asia, and Latin America are boosting market growth. Continued investment and support in these regions will expand screening coverage and patient access in the coming years.

Segmental Insights

By Technology Insights

Why Did the Hemoglobin Electrophoresis Segment Dominate in the Market in 2025? 

The hemoglobin electrophoresis segment held the largest sickle cell anemia testing and screening market share in 2025, due to its high diagnostic accuracy, reliability, and widespread clinical acceptance for identifying abnormal hemoglobin variants. Its cost-effectiveness, standardized protocols, and routine use in hospitals and reference laboratories for confirmatory testing supported strong adoption across both developed and developing healthcare systems.

Point-of-care Tests

The point-of-care tests segment is expected to grow at the fastest CAGR during the forecast period due to increasing demand for rapid, affordable, and easy-to-use diagnostic solutions. These tests support early detection, especially in newborn and community-based screening programs. Their minimal infrastructure requirement quick turnaround times, and suitability for rural and resource-limited settings are accelerating adoption across emerging and developed healthcare markets.

By Age Group Insights

What made the Newborn Screening (12 months and below) Segment Dominant in the Market in 2025?

The newborn screening (12 months and below) segment led the sickle cell anemia testing and screening market due to mandatory screening policies in many countries and the critical need for early diagnosis of sickle cell anemia. Early detection enables timely interventions, reduces infant mortality, and prevents severe complications. Strong government support, integration into routine neonatal care, and growing awareness among healthcare providers and parents further drove widespread adoption of newborn screening programs.

Other age groups (1 to 25 & above 60 years)

The other age groups (1 to 25 & above 60 years) segment is expected to grow at the fastest CAGR due to increasing diagnosis of undetected cases in adolescents and adults. Rising awareness, expanded carrier screening, and improved access to healthcare services are driving testing beyond newborns. Additionally, genetic counselling needs, premarital screening initiatives, and better disease management programs are boosting demand for testing in this age group.

By Sector Type Insights

How Does the Government Labs Segment Dominate the Market in 2025?

The government labs segment dominated the sickle cell anemia testing and screening market due to strong public funding and extensive healthcare infrastructure. These labs support large-scale and diagnostic programs under national health initiatives. With standardized protocols, trained staff, and high patient volumes, they provide reliable and affordable testing. Their role in early disease detection and preventive care ensures widespread accessibility, reinforcing their leading position in the market.

Private Labs

The private labs segment is expected to grow at the fastest CAGR due to increasing demand for personalized, convenient, and rapid diagnostic services. Rising awareness of early disease detection, advanced technologies, and high-quality testing options drives patient preference for private facilities. Flexible service offerings, shorter turnaround times, and collaborations with healthcare providers further boost their adoption, positioning private labs for significant market growth during the forecast period.

Regional Insights

North America: Advanced Screening and Early Diagnosis Drive Market Dominance

North America dominated the sickle cell anemia testing and screening market in 2025 due to advanced healthcare infrastructure, widespread newborn screening programs, and high awareness of early diagnosis. Strong government support, well-established reimbursement policies, and availability of advanced diagnostic technologies further fueled market growth. Additionally, significant investments by private and public sectors in research and development, along with growing patient awareness, contributed to the region’s leading position.

U.S. Leads Market with Innovation and Growing Awareness

The U.S. led the sickle cell anemia testing and screening market in 2025 by generating the highest revenue, driven by advanced healthcare infrastructure, widespread newborn screening, and high patient awareness. Strong government support, established reimbursement policies, and the presence of key players offering innovative diagnostic solutions further strengthened market growth, securing the country’s top position.

Asia Pacific Posed for Rapid Growth in Sickle Cell Testing Driven by Awareness and Advanced Diagnostics

Asia Pacific is expected to grow at the fastest CAGR in the sickle cell anemia testing and screening market due to increasing awareness of sickle cell anemia, rising healthcare investments, and expanding diagnostic infrastructure. Growing government initiatives, adoption of advanced screening technologies, and a large patient population drive demand. Additionally, the presence of emerging private labs and rising early detection programs further accelerates market growth in the region.

India Leads the Race in Sickle Cell Testing with Rising Awareness and Improved Diagnostics

India is expected to grow at the fastest CAGR due to increasing awareness of sickle cell anemia, expanding healthcare infrastructure, and government-led screening programs. Rising demand for early diagnosis, adoption of advanced diagnostic technologies, and growth of private laboratories further boost the market. A large patient population and focused public health initiatives accelerate growth during the forecast period.

Europe Set for Strong Growth in Sickle Cell Testing with Rising Awareness and Advanced Healthcare

Europe is expected to grow at a notable CAGR in the sickle cell anemia testing and screening market due to increasing government initiatives, well-established healthcare infrastructure, and rising awareness of sickle cell anemia. Adoption of advanced diagnostic technologies, availability of specialized private and public laboratories, and growing investments in early screening programs contribute to market growth. Supportive reimbursement policies further enhance regional adoption during the forecast period.

UK Sees Rapid Uptake in Sickle Cell Testing Driven by Decentralized Diagnostics

The UK is expected to witness rapid sickle cell anemia testing and screening market growth due to increasing demand for decentralized and point-of-care testing, improved access to genetic diagnostics, and rising focus on community-based healthcare delivery. Growing investments in laboratory automation, digital health integration, and enhanced referral pathways for high-risk populations further support faster market expansion during the forecast period.

Value Chain Analysis

R&D

• Improved accuracy and coverage of newborn screening programs
• Development of affordable point-of-care tests for low-resource settings
• Advancement of non-invasive prenatal testing using maternal blood DNA
• Faster molecular diagnostics to differentiate sickle cell trait from SCA
• Key Players: Bio-Rad Laboratories, Thermo Fisher Scientific, Roche Diagnostics, PerkinElmer, Siemens Healthineers

Clinical Trials

• Evaluation of next-generation diagnostic approaches to improve early and accurate disease identification
• Gene-based clinical studies using genome editing technologies to stimulate fetal hemoglobin production and reduce disease severity
• Stem cell–focused trials aimed at long-term disease modification
• Studies assessing optimized blood transfusion strategies, including automated exchange methods, to minimize complications and organ damage
• Key Players: Vertex Pharmaceuticals, CRISPR Therapeutics, Bluebird Bio, Novartis, Sangamo Therapeutics

Patient Support and Services

• Government-led programs support free or subsidized screening and early detection initiatives
• Hospitals and public health institutions provide confirmatory testing and follow-up care
• NGOs and community organizations conduct outreach programs, awareness campaigns, and mass screening drives
• Genetic counseling services assist families through premarital and prenatal guidance
• Access to treatment support, including medications, transfusions, and financial assistance
• Key Players: Ministry of Health and Family Welfare, National Health Mission, ICMR, Red Cross Society, Doctors Without Borders

Top Vendors in the Market & Their Offerings

SWOT Analysis

Strengths

• Strong clinical need for early diagnosis and preventive screening
• Government-supported newborn and population screening programs
• Advancements in molecular and point-of-care diagnostic technologies
• Growing awareness among healthcare providers and patients

Weaknesses

• High cost of advanced diagnostic and genetic tests
• Limited access to screening in low-resource and rural regions
• Dependence on public funding in several markets
• Shortage of trained laboratory professionals in developing areas

Opportunities

• Expansion of newborn and prenatal screening initiatives globally
• Growing adoption of rapid and point-of-care testing solutions
• Untapped markets in emerging economies with high disease prevalence
• Increasing public–private partnerships and R&D investments

Threats

• Inconsistent reimbursement policies across regions
• Regulatory complexities for diagnostic approvals
• Low awareness in certain populations despite high disease burden
• Competition from alternative or emerging diagnostic approaches

What are the Recent Developments in the Sickle Cell Anemia Testing and Screening Market?

• In September 2025, MedAccess provided a $2.5 million facility to Hemex Health to scale up production and distribution of the Gazelle® sickle cell diagnostic platform in India, the Middle East, and sub-Saharan Africa, improving access to rapid screening tools.
• In May 2025, the Clinton Health Access Initiative secured a deal to reduce the cost of HemoTypeSC rapid diagnostic tests to roughly $1 per test, enabling large-scale, affordable screening in low- and middle-income countries.

Segments Covered in the Report

By Technology

• Hemoglobin Electrophoresis
  • Isoelectric Focusing
  • Others
• High-Performance Liquid Chromatography (HPLC)
  • Point-of-Care Tests
  • Lateral Flow Immunoassay
  • Paper-Based Rapid Diagnostics
  • Others
• Other Tests

By Age Group

• Newborn Screening (12 months and below)
• Adult Screening (25 to 60 years)
• Other Age Groups (1 to 25 & above 60 years)

By Sector Type

• Government Labs
• Private Labs
• Corporate Labs
• PPP (Public-Private-Partnerships)

By Region

• North America
  • U.S.
  • Canada
• Europe
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Denmark
  • Sweden
  • Norway
• Asia Pacific
  • Japan
  • China
  • India
• South Korea
  • Australia
  • Thailand
• Latin America
  • Brazil
  • Mexico
  • Argentina
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Kuwait